Abstract
AbstractThe wide interest in developing improved therapies for cancer has led to a dramatic increase in the number of highly potent active pharmaceutical ingredients (HAPIs) under development and in use today. The following is an overview of the “cradle‐to‐grave” health risk issues that must be addressed during drug development of a HAPI, as seen from a drug sponsor's perspective. Although much of the handling of the drug may be outsourced, this article points out the principal responsibilities of the drug sponsor and what they need to know about the responsibilities of the CMOs and CROs in handling HAPIs to ensure the most effective partnership. The major focus is on manufacturing activity, but upstream and downstream issues are also presented. Drug Dev Res 71:420–428, 2010. © 2010 Wiley‐Liss, Inc.
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